Test Cartridge

GUDID 06944413802865

Edan Instruments, Inc.

Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE)

• Primary Device ID: 06944413802865
• NIH Device Record Key: f7b99feb-2f01-4f1d-ae7f-9bbe4be5ed74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Test Cartridge
• Version Model Number: BG8
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413801912 [Package]; Contains: 06944413802872; Package: [25 Units]; In Commercial Distribution
GS1	06944413802865 [Package]; Contains: 06944413801912; Package: [4 Units]; In Commercial Distribution
GS1	06944413802872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151978

FDA Product Code

• CHL: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Test Cartridge]

• 06944413802940: BC4
• 06944413802919: BG3
• 06944413802865: BG8